Chest Compression Synchronized Ventilation (CCSV) - An Exploratory Post Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Oxygenation
研究概览
简要总结
The main goal of this observational study is the evaluation of Chest Compression Synchronized Ventilation (CCSV) regarding oxygenation in terms of PaO2 assessed by routine blood gas analysis, hemodynamic effects, 30-day outcome and safety in comparison to Intermittent Positive Pressure Ventilation (IPPV) as data in humans is sparse especially in direct comparison to other ventilation modes.
Cardiac arrest patients in Vienna, Austria will be preclinically randomized (IPPV and CCSV) and ventilated accordingly during CPR. Differences in oxygenation, decarboxylation, systemic perfusion and cerebral oxygenation, the patient's 30-day outcome as well as ventilator-associated adverse events (e.g., pneumothorax) will be recorded and analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Correct endotracheal intubation (seen by capnography)
- •The patient is being treated by the Vienna Emergency Medical Services within the scope of emergency ventilation.
- •MEDUMAT Standard from Weinmann Emergency is used.
- •Mechanical ventilation is performed according to the specified indications.
排除标准
- •Patients eligible for eCPR (as defined by the standard operating procedure of the Emergency Medical Service Vienna)
- •Patients recovering (reaching sustained ROSC) before starting mechanical ventilation or in the first three minutes of it
- •Any other mechanical ventilation during the ongoing CPR before study inclusion
- •Traumatic cardiac arrest
- •Suspected or known pregnancy
- •Clinically suspected (tension-)pneumothorax
结局指标
主要结局
Oxygenation
时间窗: 24 months
Difference in PaO2 between IPPV and CCSV group
次要结局
- systemic perfusion(24 months)
- Decarboxylation(24 months)
- patient outcome(27 months)
- ventilator-associated adverse events(27 months)
研究者
Sebastian Schnaubelt, MD
Adjunct Professor
Medical University of Vienna